Prenatal affective cognitive training to reduce the risk of postpartum depression (PACT): study protocol for a randomized controlled trial

Background Postpartum depression (PPD) affects 30–50% of women with a history of previous depression or bipolar disorder and 8% of women with no history of depression. Negative cognitive biases in the perception of infant cues and difficulties with emotion regulation are replicated risk factors. Current interventions focus on detecting and treating rather than preventing PPD. The aim of this randomized controlled intervention trial is therefore to investigate the potential prophylactic effects of prenatal affective cognitive training for pregnant women at heightened risk of PPD. Methods The study will enrol a total of 292 pregnant women: 146 at high risk and 146 at low risk of PPD. Participants undergo comprehensive assessments of affective cognitive processing, clinical depressive symptoms, and complete questionnaires at baseline. Based on the responses, pregnant women will be categorized as either at high or low risk of PPD. High-risk participants will be randomized to either prenatal affective cognitive training (PACT) or care as usual (CAU) immediately after the baseline testing. The PACT intervention is based on emerging evidence for efficacy of affective cognitive training approaches in depression, including cognitive bias modification, attention bias modification, mindfulness-inspired emotion regulation exercises, and working memory training. Participants randomised to PACT will complete five individual computerised and virtual reality-based training sessions over 5 weeks. The primary outcome is the difference between intervention arms in the incidence of PPD, assessed with an interview 6 months after birth. We will also assess the severity of depressive symptoms, rated weekly online during the first 6 weeks postpartum. Discussion The results will have implications for future early prophylactic interventions for pregnant women at heightened risk of PPD. If the PACT intervention reduces the incidence of PPD, it can become a feasible, non-invasive prophylactic strategy during pregnancy, with positive mental health implications for these women and their children. Trial registration ClinicalTrials.gov NCT06046456 registered 21-09-2023, updated 08-07-2024. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-024-08316-1.


Study Description
Brief Summary: Many pregnant women face the risk of experiencing depression after giving birth, especially if they've previously dealt with depression.
The goal of this study, is to test if our newly developed Prenatal Affective Cognitive Training (PACT) intervention, can decrease the likelihood of post partum depression.In the study, 226 pregnant women, some of whom are considered high risk due to past mental illness or psycho-social risk factors, will participate.The high-risk women will be divided into two groups.One group will undergo the PACT training, which involves computer and virtual reality exercises spanning five weeks, designed to improve mood and emotional regulation.The other group will receive usual care.The study also involves a low-risk group (n=146), although these individuals are not part of the intervention trial but are merely followed up with the same assessments for background comparisons.The main aim is to observe whether the women who undergo PACT intervention are less prone to depression after childbirth compared to those who do not.

Arms Assigned Interventions Receive the intervention
A psychological intervention using computer-and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation No Intervention: CAU Receive care as usual, i.e., the standard care provided to pregnant women without any additional experimental interventions.It typically involves routine prenatal care, which may include regular check-ups, medical assessments, and general support from healthcare professionals NOTE : An Arm/Group Title this short may not be sufficiently descriptive, especially for later use in results.NOTE : An Arm/Group Title this short may not be sufficiently descriptive, especially for later use in results.

Outcome Measures
Primary Outcome Measure: 1 6.Mother-child interaction Tertiary outcome involve assessing differences in mother-child interaction measures (e.g., sensitivity, intrusiveness, dyadic reciprocity and neural synchrony) between the PACT and CAU groups as measured with behavioural coding (Coding Interactive Behaviour) and fNIRS brain scan.
[Time Frame: Eight -eighteen months after birth] 7. Change in affective cognition Tertiary outcome involve assessing differences in the changes in facial expressions and visual attention towards infant stimuli (from T0 to T1 during pregnancy) between the PACT and CAU groups, as measured with computerized testing . The incidence of PPD during the first six months after birth, assessed with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN) The primary outcome is the difference between mothers receiving PACT versus CAU in the incidence of PPD during the first six months after birth, assessed by a clinician blind to group status with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN) [Time Frame: Six months after birth] Secondary Outcome Measure: 2. Change in negative cognitive bias Differences between participants receiving PACT and CAU in the change in negatively biased cognitive processing of infant stimuli from baseline to follow-up during pregnancy (T1) as measured with computerized testing [Time Frame: In third trimester of pregnancy] 3. Self-rated depressive symptoms Differences between participants receiving PACT and CAU in severity of depressive symptoms during the first six weeks after birth measured with the Edinburgh Postpartum Depression Scale [Time Frame: Within six weeks after birth] 4. Self-rated parental stress Self-rated parental stress with the Parental Stress Scale at six months after birth.[Time Frame: Six months after birth] Other Pre-specified Outcome Measures: 5. Infant development Tertiary outcome involve assessing differences in infant development as measured with the Bayley Scales version 4 between the PACT and CAU groups [Time Frame: Eight -eighteen months after birth]